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Regulatory

Latest Headlines

The clinical side of orphan drug use has many twists and turns, not least of which is matching patient ability to pay with the right drug and an openness to understand the dynamics of a "Dallas Buyers Club" approach to use.

Pfizer may have FDA approval for meningitis B vaccine Trumenba, but it can only take the jab so far without a nod from the CDC's Advisory Committee on Immunization Practices (ACIP). Now, though, it's got some positive new data on the shot just in time to help it make its case for one.

Another startup from controversial med tech visionary Alfred Mann is making its way to the fore: Bioness. He founded the company in 2004. Now, Bioness has gained clearance from the FDA for its StimRouter, an implantable neuromodulator to treat chronic, intractable pain of peripheral nerve origin. It's the only implant cleared by FDA specifically for peripheral nerve stimulation.

Another GMP issue has landed in Sun Pharma's inbox. The latest setback sees the Indian drugmaker forced to recall almost 3,300 bottles of its antiepileptic drug levetiracetam from the U.S. after the batches failed a 6-month dissolution test.

Endo Pharmaceutical's investigational Belbuca buccal film strip for severe chronic pain has been accepted for review by the FDA, marking a win for the BioErodible MucoAdhesive technology to deliver drugs across mucosal surfaces like the inside of the cheek. And BEMA platform developer BioDelivery Sciences receives a $10 million milestone payment.

Going against the advice of its independent experts, the FDA approved Novartis' new blood cancer drug for patients with particularly deadly forms of multiple myeloma, looking past some serious safety issues and concerns about the drug's supporting data.

Shares of Celldex Therapeutics shot up 20% this morning after the biotech announced that the FDA had provided its breakthrough therapy designation for rindopepimut (Rintega), an experimental drug for patients with EGFRvIII-positive glioblastoma.

The FDA has sent a Form 483 to Lupin listing 6 observations its inspectors made during a visit to one of the company's production plants in central India last month. However, the ticking off has done little to slow the rate of approvals for the facility, which has racked up two site transfer nods and one ANDA go-ahead since receiving the Form 483.

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THE LIBRARY: WEBINAR

In December 2014, FDA released the Guidance for Industry "Providing Regulatory Submissions in Electronic Format—Standardized Study Data." This webinar will review the guidance and discuss the implications for Sponsors currently conducting studies and for those starting new studies soon. Register today!

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